Director - Quality Systems

The Director of Quality Systems is primarily responsible for providing quality oversight, defining strategies for implementation and continual improvement of the Quality System and support at Caris Life Sciences.

Job Responsibilities:

The Director of Quality Systems is responsible for ensuring that the Caris Quality System is implemented to ensure compliance with all applicable regulations. The position will work in collaboration with the Laboratory Operations, Product Development and Regulatory teams to provide QA oversight throughout the product lifecycle.

Requirements:

Background

Working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems.
Demonstrated success independently working with cross-functional teams.
Experience providing QA support and oversight of GMP manufacturing operation including batch release.
Experience in hosting regulatory inspections.
Experience with equipment, facilities and utility system qualifications activities in a GMP setting.
Experience successfully leading event investigations, Risk Management (ISO 14971), Root Cause Analysis (RCA), and CAPA.
Excellent technical report writing skills.
Strong communication, interpersonal and problem-solving skills and detail oriented.

Accountability/Scope:

Implement and provide oversight of development and commercial change controls, Risk Management, GMP investigations, associated CAPAs and Effectiveness Checks. Lead the investigation/CAPA triage meetings (as necessary) and collaborate with customer groups to ensure quality systems are monitored and established metrics are met.
Establish and generate performance metrics, trends; including site metrics for investigation/CAPA, management review, etc.
Lead compliance walkthroughs of the site and help drive the closure of observations.
Participate in inspection readiness activities and provide support during regulatory site inspections.
Regulatory Inspection preparation, support internal preparation in the overall regulatory inspection covering inspection preparations, execution of regulatory inspections, preparation of responses to health authorities and inspection follow-up.
Support internal and external audit plans for Caris development programs.
Perform data audits of documentation intended for submission to regulatory health authorities (e.g. FDA, EMA).
Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication.
Act as a trusted advisor to the leadership team by providing compliance guidance through collaborative review and working to gain a better understanding of their needs and facilitate resolution of quality issues in a timely manner.

Education:

Master's degree with minimum 7 years of relevant work experience, or Bachelor's degree in a scientific or related field with minimum 10 years of relevant work experience, or relevant comparable background.

Physical Demands:

Employee may be required to lift routine office supplies and use standard office equipment.
Ability to sit for extended periods of time.
Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.